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A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Adult Subjects With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

Thank you

Trial Information

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Adult Subjects With Advanced Solid Tumors


This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm, dose-escalation
(3+3) study to evaluate the safety, tolerability, antitumor activity, PK, and immunogenicity
of MEDI0639 in adult subjects with advanced solid tumors refractory to standard therapy or
for which no standard therapy exist. Up to 63 subjects will be enrolled at approximately 3
to 5 study centers in North America.


Inclusion Criteria:



- Histologically or cytologically confirmed solid tumors that are refractory to
standard therapy or for which no standard therapy exist

- Age ≥ 18 years

- ECOG Performance Status of 0 or 1

- LVEF (measured by Echocardiogram) > 50%

- No gastrointestinal bleeding within 1 year of study entry.

- Adequate organ and marrow function:

- Hemoglobin ≥ 10g/dL

- Absolute Neutrophil Count ≥ 1500/mm3

- Platelet Count ≥ 100,000/mm3

- AST & ALT ≤ 2.5 x ULN

- Bilirubin ≤ 1.5 x ULN

- Cr Cl ≥ 50 mL/min (as determined by the Cockcroft-Gault equation or by 24-hour
urine collection)

- Prior therapy against VEGF or VEGFRs including, but not limited to bevacizumab,
sunitinib, sorafenib, pazopanib, motesanib (AMG706), or cediranib (AZD2171), is
permitted so long as the agent does not have any known activity against DLL4 and the
last dose received s at least 6 weeks prior to first dose of MEDI0639.

- Life expectancy ≥ 12 weeks

- Females of childbearing potential must be surgically sterile, have a sterile male
partner, be premenarchal or at least 2 years postmenopausal, practice abstinence or
otherwise must use 2 effective methods of contraception from the time of initiation
of investigational product.

- Males, unless surgically sterile, must use 2 effective methods of contraception with
a female partner and must agree to continue using such contraception for 90 days
after the last dose of MEDI0639

Exclusion Criteria:

- Concurrent enrollment in another investigational clinical study

- Receipt of any investigational anticancer therapy within 4 weeks prior to the first
dose of MEDI0639 or in the case of monoclonal antibodies, 6 weeks prior to the first
dose of MEDI0639

- Concurrent or previous treatment with inhibitors of DLL4

- Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal
therapy for cancer treatment

- Known bleeding diathesis, esophageal varices, or angioplasty

- Pulmonary hemorrhage or gross hemoptysis within 12 months

- Known arterial or venous thrombosis or pulmonary embolism within 2 years

- Concurrent use of systemic low molecular weight heparin or low dose warfarin

- Presence of brain metastases

- Cerebrovascular accident or transient ischemic attack within 2 years

- Cardiovascular events, such as myocardial infarction, unstable/severe angina,
coronary/peripheral artery bypass graft, unstable cardiac arrhythmia requiring
medication, congestive heart failure (NYHA > class II), within 2 years

- Tumors with squamous cell histology

- Major surgical procedure within 90 days

- Pregnancy or lactation

- Known HIV positive or Hepatitis A, B, or C infection

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of the MTD

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

David Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Food and Drug Administration

Study ID:

CD-ON-MEDI0639-1078

NCT ID:

NCT01577745

Start Date:

April 2012

Completion Date:

June 2015

Related Keywords:

  • Solid Tumors
  • Cancer
  • Neoplasms

Name

Location

Research SiteDanbury, Connecticut  
Research SiteBattle Kreek, Michigan  
Research SiteAlbany, New York  
Research SiteAbilene, Texas  
Research SiteAuburn, Washington